BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET CLAVE PORT, CLAVE Y-SITE

    MDR report key: 2843727 · Received October 29, 2012

    Report

    Report Number
    2843727
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 29, 2012
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S CENTRAL LINE WAS FLUSHED WITH NORMAL SALINE AND THE MALE ADAPTER OF THE PRIMARY PLUMSET WAS ATTACHED TO THE PATIENT'S CENTRAL LINE. THE INFUSION PUMP WAS STARTED AND IV FLUIDS STARTED TO INFUSE. THE NURSE THEN ATTACHED THE SECONDARY PIGGYBACK TUBING TO THE SECONDARY CLAVE PORT. AFTER ATTACHING THE SECONDARY TUBING, THE PRIMARY IV FLUIDS STARTED BUBBLING UP AND LEAKING JUST UNDER THE SECONDARY BLUE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUMSET CLAVE PORT, CLAVE Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA * 15114 5H

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR CHEMOTHERAPY